Study on PT-112 for Patients with Thymoma and Thymic Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT05104736
This clinical trial is testing a new drug, PT-112, to see if it can help shrink tumors in patients with thymoma or thymic cancer that has returned or worsened after previous treatments. The study aims to find out if PT-112 can be a new treatment option for these cancers.
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Program Overview
This study is exploring the potential of a new drug, PT-112, to treat thymoma and thymic carcinoma, which are types of cancer that affect the thymus gland. Currently, there are no approved drugs specifically for these cancers when they come back or get worse after initial treatment. PT-112 works by killing cancer cells and boosting the immune system to fight the cancer. The main goal is to see if PT-112 can help reduce the size of tumors in patients who have already tried other treatments.
Description
This study is designed to test the effectiveness of PT-112, a new drug, in treating thymoma and thymic carcinoma. These are rare cancers that affect the thymus gland, and there are currently no approved treatments for cases where the cancer returns or progresses after initial therapy. PT-112 is a unique drug that not only kills cancer cells but also helps the immune system fight the cancer.
Participants in the study will receive PT-112 through an infusion, which is a process where the drug is delivered directly into the bloodstream through a small tube in a vein. The treatment is given in cycles, with each cycle lasting 28 days. During the first cycle, participants will receive the drug on days 1 and 15, and then on day 1 of each following cycle. The study will continue as long as participants can tolerate the treatment and their cancer does not worsen, for up to 8 years.
Throughout the study, participants will have regular check-ups, including physical exams, blood and urine tests, and heart function tests. They will also have scans every 8 weeks to monitor the size of their tumors. Participants may choose to have additional tests, such as tumor biopsies, to help researchers understand how the drug is working.
After stopping the treatment, participants will have follow-up visits 2 weeks and 4 weeks later, and then every 3 months for up to 8 years to monitor their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of thymoma or thymic carcinoma.
- Have previously received at least one platinum-based chemotherapy treatment or have refused standard chemotherapy.
- The cancer must have progressed and be measurable by scans.
- Have good kidney, liver, and blood cell function.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 6 months after.
- Men with partners of childbearing potential must agree to use contraception during the study and for 6 months after.
- Participants with treated brain metastases are eligible if they have recovered from any side effects and do not need steroids.
- Must be able to understand and sign a consent form to participate.
Exclusion Criteria
- Allergic reactions to similar drugs as PT-112.
- Currently taking non-permitted drugs or anticancer treatments within 14 days before starting the study.
- Major surgery within 14 days before joining the study.
- Active infections requiring treatment, including hepatitis B, hepatitis C, or HIV with a detectable viral load.
- Previous cancer within the last 2 years, except for certain skin, cervical, or thyroid cancers.
- Uncontrolled illnesses, such as heart failure, lung disease, or gastrointestinal issues, within the past 6 months.
- Known alcohol or drug abuse.
- Recent administration of live vaccines, except for COVID-19 vaccines.
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